ROEHAMPTON UNIVERSITY
SENATE TASK GROUP ON POLICY ON ANIMAL EXPERIMENTATION
Ethical Issues Relating to Animal Experimentation
This document contains selected extracts from the official “Guidance on the
Operation of the Animals (Scientific Procedures) Act 1986” to be used in
deciding whether any proposed animal experimentation shall require an
application to the Home Office for licensing. Sections referred to in the text
below can be found in the complete Guidelines which are at:
http://www.archive.official-documents.co.uk/document/hoc/321/321-00.htm
They are intended to assist School ethics groups in reaching a decision on a
particular proposal. If appropriate, School ethics groups should also consider
seeking advice from the Home Office BEFORE approving a proposal for
submission to the University Ethics Board e.g. see 2.16 below.
Applications for a project licence forwarded to the University Ethics Board
should make clear reference to the Guidelines, including references to other
parts of the Guidelines and schedules to the act as appropriate.
Selected sections included from chapter 2
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Scope of the Act
Definition of a protected animal
Definition of a regulated procedure
Procedures which are NOT covered by the Act
The purpose of the procedure
Licences and certificates
Project licences
Certificate of designation
Places other than designated establishments
Selectred sections included from chapter 5
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Alternatives – replacement, reduction and refinement
Cats, dogs, equidae and non-human primates
Other restrictions
Project licences for education and training
SCOPE OF THE ACT
2.1 The Animals (Scientific Procedures) Act 1986 regulates any experimental or other
scientific procedure applied to a "protected animal" [Section 1] that may have the
effect of causing that animal pain, suffering, distress or lasting harm [Section 2]. A
procedure so defined by the Act is referred to in this Guidance as a "regulated
procedure".
2.2 The Act requires that, before any regulated procedure is carried out, it must be
part of a programme specified in a project licence and carried out by a person holding
appropriate personal licence authorities. In addition, work must normally be carried
out at a designated scientific procedure establishment [Sections 3 and 6].
2.3 Regulated procedures can only be authorised and performed if there are no
scientifically suitable alternatives that replace animal use, reduce the number of
animals needed or refine the procedures used to cause less suffering - these are known
as the 3Rs. In addition, the likely benefits (to humans, other animals or the
environment) must be weighed against the likely welfare costs to the animals
involved.
2.4 The Act requires that applications for licences to carry out procedures on animals
be considered on a case by case basis.
2.5 The Act also controls the breeding and supply of certain types of animal (where
the animals are intended for use in regulated procedures) [Section 7]. The types of
animal are listed in Schedule 2 to the Act.
DEFINITION OF A PROTECTED ANIMAL
2.6 The Act defines a "protected animal" as any living vertebrate, other than
man [Section 1(1)]. The invertebrate species Octopus vulgaris has been
added by means of the Animals (Scientific Procedures) Act (Amendment)
Order 1993.
2.7 Protection extends to certain immature forms from the following stages of
development:


mammals, birds and reptiles - from halfway through the gestation or
incubation period;
fish, amphibia and Octopi vulgaris - from the time at which they
become capable of independent feeding.
2.8 Under Section 2(2)(c), protection is also provided when regulated
procedures are applied at an earlier stage of development if:
(i) the animal is to be allowed to live beyond the stage of development set out
in paragraph 2.7 above; and
(ii) the procedure may result in pain, suffering, distress or lasting harm after
the animal has reached that stage of development.
For example, licences are required for virus propagation in embryonated bird
eggs if inoculation takes place before the mid-point of incubation and if the
embryo is allowed to survive into the second half of the incubation period.
2.9 Gestation and incubation periods, and the times at which larval stages
become capable of independent feeding, vary widely between species. A
thorough knowledge of the developmental stages for the types of animal
being used, and the stage of development that will be attained in the course of
the work, is necessary before planning or performing procedures using foetal,
larval or embryonic forms.
2.10 The Secretary of State may, by making an Order in Parliament, extend
the definition of a protected animal or alter the stage of development at which
immature forms become protected [Section 1(3)].
2.11 A protected animal is regarded as being alive until permanent cessation
of its circulation or the destruction of its brain has occurred [Section 1(4)]. As
brain destruction is incomplete in decerebrate animals, such animals are
considered to be living for the purposes of the Act. They are therefore
protected. Appropriate licence authorities are required both for the
decerebration and for the use of animals so prepared for experimental or
other scientific purposes.
2.12 Throughout the Guidance, unless otherwise stated, all references to
"animals" should be taken, according to the context, as referring to:


i.
ii.
protected animals that are held for use in, or are undergoing regulated
procedures, or have been used in regulated procedures; or
protected animals of the type listed in Schedule 2 of the Act that:
are bred, or are kept for breeding, for use in regulated procedures, or
are kept to be supplied for use in regulated procedures.
DEFINITION OF A REGULATED PROCEDURE
2.13 A "regulated procedure" is defined by Section 2(1) of the Act as "any
experimental or other scientific procedure applied to a protected animal which
may have the effect of causing that animal pain, suffering, distress or lasting
harm".
2.14 "Pain, suffering, distress and lasting harm" encompass any material
disturbance to normal health (defined as the physical, mental and social wellbeing of the animal). They include disease, injury and physiological or
psychological discomfort, whether immediately (such as at the time of an
injection) or in the longer term (such as the consequences of the application
of a carcinogen).
2.15 Regulated procedures may be acts of commission (such as dosing or
sampling) or of deliberate omission (such as withholding food or water).
2.16 In countries implementing European Directive 86/609/EEC, a common
threshold has been standardised for regulating the use of animals for
experimental or other scientific purposes. Regulation starts at the "skilled
insertion of a hypodermic needle". The Home Office has determined
equivalent thresholds for the regulation of other classes of procedure, such as
psychological stress, dietary manipulations and environmental changes. The
Home Office can advise potential applicants on a case by case basis about
thresholds established in these and other contexts.
2.17 An experimental or other scientific procedure applied to a protected
animal is also a regulated procedure if it is part of a series or combination of
otherwise non-regulated procedures that together may have the effect of
causing that animal pain, suffering, distress or lasting harm [Section 2(2)]. For
example, multiple or cumulative minor changes to the environment may cause
sufficient disturbance to be regulated, even if the individual changes do not
warrant regulation. The Home Office can advise on a case by case basis
when specific combinations of procedures would be regulated.
2.18 Anything done for the purpose of, or liable to result in, the birth or
hatching of a protected animal that may as a result of the procedure
experience pain, suffering, distress or lasting harm is also a regulated
procedure [Section 2(3)]. Thus,



the breeding of animals with harmful genetic defects;
the manipulation of germ cells or embryos to alter the genetic
constitution of the resulting animal; and
the subsequent breeding of such genetically-modified animals
are regulated if the intention is to maintain the animals produced beyond
midway through gestation or incubation. (Paragraphs 2.7 and 2.8 above
define stages of development. Paragraphs 8.13and 8.14 deal with release of
genetically modified lines from the controls of the Act.)
2.19 Under Section 2(4), procedures are regulated even if any pain, suffering,
distress or lasting harm that would otherwise have resulted are controlled or
alleviated by:



anaesthetics or other substances to sedate, restrain or dull perception;
prior decerebration; or
any other procedure rendering the living animal insentient.
Thus, procedures are regulated, even when performed under general
anaesthesia, if the effect on a normal conscious animal would be to cause
pain, suffering, distress or lasting harm.
2.20 Furthermore, the administration of an anaesthetic or analgesic or other
measure to sedate, restrain or dull the perception of pain in a protected
animal is itself a regulated procedure if it is carried out for an experimental or
other scientific purpose [Section 2(4)].
2.21 Under Section 2(7), the humane killing of a protected animal is a
regulated procedure only if:



the animal is killed for an experimental or other scientific purpose; and
the place where it is killed is a designated establishment; and
the method employed is not one appropriate to the animal as described
in Schedule 1 of the Act (see paragraph 2.33).
2.22 The removal of organs, blood or other tissue from a protected animal for
an experimental or other scientific purpose under general anaesthesia is also
considered to be a regulated procedure even if the animal is not allowed to
recover consciousness, as neither has the circulation ceased nor has the
brain been destroyed before the procedure is commenced. Exsanguination,
with or without general anaesthesia, is not therefore a recognised humane
method of killing listed in Schedule 1 to the Act.
2.23 Removal of blood or other tissues from freshly killed animals, where the
circulation has ceased or the brain has been destroyed, is not a regulated
procedure.
PROCEDURES WHICH ARE NOT REGULATED BY THE ACT
2.24 In addition to procedures which do not reach the threshold for regulation
(see paragraph 2.16), the controls of the Act do not extend to any of the
following:



procedures applied to animals in the course of recognised veterinary,
agricultural or animal husbandry practice [Section 2(8)] (see
paragraphs 2.25and 2.26);
the ringing, tagging or marking of an animal, or the application of any
other humane procedure for the sole purpose of identification of
protected animals, if this causes no more than momentary pain or
distress and no lasting harm [Section 2(5)] (see paragraphs 2.27-2.29);
the administration of materials to animals as part of a medicinal test in
accordance with the provisions of Section 32 of the Medicines Act
1968, if the substance or article is administered in accordance with the
provisions of Subsection (4) of that Section or of an Order issued under
Section 35(8)b of that Act [Section 2(6) of the 1986 Act] (see
paragraphs 2.30 and 2.31);
the humane killing of an animal by a method appropriate to the animal
under Schedule 1 to the 1986 Act [Section2(7)] (see paragraphs 2.32
and 2.33).
But even in situations where the 1986 Act does not extend specific
protections, the provisions of the Protection of Animals Act 1911 (Scotland
1912) apply. This is the general legislation protecting animals against
unnecessary cruelty.
Recognised veterinary, agricultural or animal husbandry practice
2.25 The Veterinary Surgeons Act 1966 regulates veterinary practice, and the
Royal College of Veterinary Surgeons provides guidance on recognised
veterinary practice and standards of professional conduct. The Royal College
should be consulted on the interpretation of what constitutes recognised
veterinary practice and professional standards. The clinical investigation and
management of health or welfare problems is considered to constitute
recognised veterinary practice, if undertaken for the benefit of that animal or
group of animals or their progeny.
2.26 Recognised agricultural and husbandry practices (such as castration of
farm animals), performed in accordance with other animal welfare legislation
and regulations, and being used to manage or conserve the animals, are not
regulated procedures unless they are part of a scientific study.
Identification of animals
2.27 The ringing, tagging or marking of an animal or the use of any other
humane procedure for the sole purpose of enabling an animal to be identified
is not a regulated procedure if it causes only momentary pain or distress and
no lasting harm [Section 2(5)].
2.28 This threshold of "momentary pain" and "no lasting harm" differs from the
threshold set for regulated procedures (see paragraph 2.16). For example, the
micro-chipping or ear-marking of rodents is not regulated by the Act if it is
performed solely to identify the animal. Similarly, blood or DNA sampling
solely to establish the identity or provenance of an animal would not be
regulated if the intervention caused no more than momentary discomfort or
distress. But such sampling is regulated when the purpose is to confirm that
an animal has been genetically modified and when the method is judged likely
to cause pain, suffering, distress or lasting harm.
2.29 Methods of marking or identification, such as toe-clipping, which can
cause suffering in excess of this threshold are regulated when carried out for
an experimental or other scientific purpose. The Secretary of State will only
consider authorising such practices when no milder method will suffice
[Section 5(5)].
Medicines Act 1968
2.30 The administration of substances to animals in order to evaluate a
veterinary product in accordance with Section 32 of the Medicines Act 1968 or
an Order under Section 35(8)(b) of that Act is not a regulated procedure
[Section 2(6) of the 1986 Act].
2.31 Authorities under the Medicines Act do not extend to the deliberate
induction of disease, the withholding of established treatments from control
groups, or the taking of blood or other tissue samples beyond those
necessary for the clinical investigation and clinical management of the
condition to be treated. In some circumstances (for example, where a control
group is having efficacious treatment withheld or where additional blood
samplings are required to investigate pharmacokinetics), licences under the
1986 Act may also be necessary.
Humane killing by methods listed in Schedule 1
2.32 The killing of a protected animal by an appropriate, humane method
listed in Schedule 1 of the Act is not a regulated procedure, even if the killing
is performed to provide material for scientific or other experimental purposes
[Section 2(7)].
2.33 The Home Office has published a Code of Practice entitled "The
Humane Killing of Animals under Schedule 1 to the Animals (Scientific
Procedures) Act 1986". This provides detailed information on the methods to
be used, how death should be confirmed, and safeguards to be adopted to
ensure that these are performed competently.
THE PURPOSE OF THE PROCEDURE
2.34 The purpose of the procedure, as well as the level of suffering caused,
determines whether or not licence authorities under the Act are required. For
example, the taking of a blood sample or the forceful removal of a feather to
provide material solely to identify an individual, or its provenance, would not
be regulated under the Act. However, the same type of sampling to provide
data for an experimental or other scientific purpose (for example, to study
population dynamics or to determine whether or not the animal had been
genetically modified) would be regulated by the Act.
2.35 The Home Office should be consulted when there is any doubt as to
whether a proposed intervention is regulated by the Act.
LICENCES AND CERTIFICATES
2.36 Control of regulated procedures, and of places designated under the Act,
is exercised primarily by:

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personal licences for those performing regulated procedures [Section
4];
project licences for those responsible for managing programmes of
work [Section 5]; and
certificates of designation issued to individuals responsible for
compliance with the provisions of the Act at establishments where
laboratory animals are bred, kept or used and for the provision of
appropriate standards of accommodation and care [Sections 6 and 7].
2.37 No regulated procedure may be applied to a protected animal unless the
procedure, the type of animal used and the place where the work is to be
done are specifically authorised in both the relevant project and personal
licence [Section 3].
2.38 Before granting a project or personal licence or issuing a certificate of
designation, the Secretary of State shall consult an inspector appointed under
Section 18 of the Act as to whether and on what terms authorities should be
granted [Section 9(1)]. The Secretary of State may also consult an
independent assessor or the Animals Procedures Committee [Section 9(2)]
(see paragraphs 2.93-2.99).
2.39 Copies of the licence and certificate application forms, and notes on their
completion, are available from the Home Office on paper or disk. They are
also
available
on
the
Home
Office
website
http://www.homeoffice.gov.uk/ccpd/aps.htm.
2.40 Anyone considering making an application is strongly encouraged to
make early contact with the Inspectorate. Discussions of early proposals can
save applicants time when preparing applications for work that may not be
licensed or that may need substantial redrafting.
2.41 It is an offence to supply, knowingly or recklessly, false or misleading
information to obtain, or help someone else to obtain, a licence or certificate
[Section 23].
2.42 All licences and certificates are issued subject to a number of standard
conditions (see Appendices B-E) and, in some circumstances, additional
conditions may be included [Section 10(1)]. For example, the Secretary of
State may apply additional conditions to:



require reports to be made after the introduction of a novel procedure;
authorise the use of a method for killing stock animals at a designated
establishment which is not listed in Schedule 1; or
allow the use on a project licence of animals of a type listed on
Schedule 2 but obtained from non-designated sources.
2.43 Breaches of conditions of issue of licences and certificates can lead to
administrative action (including variation or revocation of the relevant
authorities) and, in some circumstances, to prosecution (see Chapter 7).
PROJECT LICENCES
2.44 A project licence may only be issued if the programme of work is for one
or more of the permissible scientific purposes defined by Section 5(3) of the
Act (see paragraph 5.9).
2.45 In deciding whether and on what terms to grant a project licence, the
Secretary of State must weigh the likely adverse effects on the animals
involved against the benefit (to humans, other animals or the environment)
likely to accrue from the programme of work [Section 5(4)]. This is discussed
at Appendix I. The Secretary of State must be satisfied that to achieve the
purpose of the study there are no suitable alternatives that do not require the
performance of regulated procedures on animals, and that full use will be
made of reduction and refinement strategies to minimise the number of
animals used and the likely pain, suffering, distress or lasting harm to be
caused [Section 5(5)]. Authorities cannot be granted when appropriate
replacement, reduction and refinement alternatives are reasonably and
practicably available.
2.46 The Secretary of State also requires that, before a licence is granted, the
application has completed the local ethical review process at the designated
establishment where the work will be performed (see paragraphs 4.13-4.17),
and that, when appropriate, project licence applicants have completed a
relevant, accredited training course (see Appendix F and paragraphs 2.732.76).
2.47 The holder of a project licence undertakes overall responsibility for:




the scientific direction, management and control of the programme of
work;
compliance with the terms and conditions of issue of the project
licence;
the supervision, training, conduct and performance of personal licence
holders working under his or her control; and
making annual statistical returns to the Secretary of State for work
started during the period covered by the return.
2.48 Project licences are valid for a maximum of five years. If a programme of
work needs to continue beyond this point, then a new licence must be
negotiated and obtained.
2.49 Project licences are covered in more detail in Chapter 5.
PERSONAL LICENCES
2.50 A personal licence is the Home Secretary's endorsement that the holder
is a suitable and sufficiently competent person to carry out specified regulated
procedures, under supervision where necessary, on specified classes of
animal as part of a programme of work authorised by a project licence.
2.51 Personal licence holders assume primary responsibility for the welfare of
the animals on which they perform regulated procedures.
2.52 Satisfactory completion of an appropriate training course is normally
required before a personal licence is issued. Such courses do not however
ensure technical competence, and further training and supervision are
generally required after a personal licence is granted. The training
requirements for new applicants are discussed in paragraphs 2.71-2.76 (see
also Appendix F).
2.53 Although personal licences continue in force until revoked, the Secretary
of State is required to review each personal licence at intervals not exceeding
five years. The licence holder must, for that purpose, provide such information
as is reasonably required. This may include details of the project licences
used in conjunction with the personal licence, and confirmation that the
personal details and techniques shown are still appropriate.
2.54 Personal licences are covered in more detail in Chapter 6.
CERTIFICATE OF DESIGNATION
2.55 Any place where regulated procedures are applied to protected animals
must be designated as a 'scientific procedure establishment' [Section 6(1)],
except where otherwise authorised by the Secretary of State on both the
project and personal licences. A certificate of designation confers the
necessary authorities.
2.56 The Act also regulates establishments that breed and/or supply for use in
regulated procedures the types of animal listed in Schedule 2 to the Act
[Section 7]. Again, a certificate of designation confers the necessary
authorities.


Designated breeding establishments may breed such animals for use
in regulated procedures or as breeding stock for designated
establishments.
Designated supplying establishments cannot breed such animals but
may obtain and supply them to other designated establishments. Cats
and dogs must normally be obtained only from designated breeders
[Section 10(3)(a)]. Genetically modified animals and animals deemed
to be harmful mutants can only be bred under licence authority at
designated scientific procedure establishments (but see paragraph
8.14).
2.57 Individual establishments may need to be designated as a combination
of scientific procedure establishment, breeding establishment and supplying
establishment.
2.58 Certificates of designation remain in force until revoked.
2.59 The Secretary of State has issued Codes of Practice for the housing and
care of animals used in scientific procedures, and for animals held in
designated breeding and supplying establishments. Whilst failure to comply
with these codes is not in itself an offence, it can be taken into consideration
in criminal or civil proceedings [Section 21(4)]. In addition, the Secretary of
State requires, through conditions added to certificates, that unless otherwise
authorised the standards of accommodation and care within designated
establishments meet or surpass the minimum provisions of these codes.
2.60 All certificate holders are required to nominate one or more Named
Animal Care & Welfare Officers (NACWOs) to be responsible for the day to
day care of the animals; and one or more Named Veterinary Surgeons, or
another suitably qualified person, to be responsible for providing advice on
animal health and welfare. The limited circumstances in which the Secretary
of State may be prepared to accept someone other than a veterinary surgeon
in the latter role are reviewed in paragraphs 4.65-4.67.
2.61 Certificate holders are responsible for the standards of accommodation
and care in the establishment. At scientific procedure establishments, they
must ensure that only authorised regulated procedures are performed. They
are also liable for the payment of annual fees to the Home Office [Section 8].
2.62 The Secretary of State also requires that certificate holders maintain
local ethical review processes (see paragraphs 4.13-4.17).
2.63 Certificate holders must ensure that inspectors appointed under the Act
are given full and prompt access to designated premises (see paragraphs
4.41-4.43). A police officer with an appropriate warrant also has right of entry
[Section 25]. There is nothing in the Act that prevents certificate holders
allowing others access to their facilities, but the Act makes no provision for
requiring certificate holders to do so.
2.64 Certificates of Designation are discussed in detail in Chapter 4.
PLACES OTHER THAN DESIGNATED ESTABLISHMENTS (PODES)
2.65 Exceptionally, a place specified in the personal and the project licence
may be a place other than a designated scientific procedure establishment
[Sections 6(1) and 6(2)].
2.66 The Secretary of State may grant such authority if it is inappropriate to
designate the place - for example, where procedures must take place at a
field site. Such authorities are coupled to additional project licence conditions
that require the licensee to notify the Home Office prior to any procedure
being performed. This allows a Home Office inspector to be present when the
work is carried out. Additional safeguards are also applied to ensure the
welfare of any animals that are to be left unattended or released to the wild
following regulated procedures (see paragraphs 5.51-5.54).
ALTERNATIVES - REPLACEMENT, REDUCTION AND REFINEMENT
5.13 The Secretary of State may not grant a project licence [Section 5(5)]
unless he is satisfied that:
i.
the purpose of the specified programme of work cannot be achieved
satisfactorily, in whole or in part, by any other reasonable and
practicable method which does not require the conduct of regulated
procedures on protected animals; and
the regulated procedures to be used are those that, while consistent
with meeting the specific objectives, minimise the suffering caused by
using:
ii.




the minimum number of animals;
animals that have the lowest degree of neurophysiological sensitivity
(that is to say, have the least capacity to experience pain, suffering or
distress);
protocols and endpoints which cause the least pain, suffering, distress
or lasting harm; and
protocols and endpoints which are most likely to produce satisfactory
scientific results.
5.14 The Secretary of State requires that applicants set out the measures
they have taken to ensure that every reasonable effort has been made to
incorporate replacement, reduction and refinement alternatives in the plan of
work and protocols requested; and that named persons are consulted during
the drafting of project licence applications.
5.15 Thus, the Secretary of State must be satisfied, on the basis of the
experimental design and the proposed means of statistical analysis, that the
programme pays due regard to using the minimum numbers of animals
required to meet the objectives of the programme of work [Section 5(5)]. It is
recognised, however, that the number of animals that need to be used can
sometimes be reduced if additional suffering is allowed to be caused to fewer
animals. The method licensed will be the one judged to cause the least
suffering or distress.
5.16 The Act requires that all experiments shall be carried out under general
or local anaesthesia unless the Secretary of State judges that the anaesthesia
would be more traumatic to the animal than the experiment itself, or that
anaesthesia is incompatible with the objective of the experiment (see
paragraphs 2.109 and 2.110 above).
5.17 If necessary, procedures without anaesthesia must use analgesics
and/or other appropriate means to minimise the pain, suffering, distress or
harm which is caused, and to ensure that no animal is subjected to severe
pain, distress or suffering. The Secretary of State will not license experiments
producing serious injury or severe pain without effective anaesthesia [Section
10(2A) and Schedule 2A in Appendix A].
5.18 The Secretary of State must be satisfied that protocols incorporate best
practice and will be applied competently. Project licence applicants are
required to provide a full description of the measures proposed to prevent or
minimise the extent, duration and incidence of the adverse effects. These may
include the specification of humane endpoints and control measures (such as
inspection schedules, the criteria used to assess the adverse effects, and the
means to be used to minimise them).
5.19 Humane endpoints should be set to provide for a number of
eventualities: the research objectives having been achieved; the realisation
that they cannot be achieved; or when welfare problems are encountered
which exceed the minimum necessary to achieve the objective.
5.20 The Secretary of State will review, and may recall and revise, licence
authorities should suitable replacement, reduction or refinement alternatives
become available during the lifetime of a project licence.
CATS, DOGS, EQUIDÆ AND NON-HUMAN PRIMATES
5.22 The Secretary of State shall not grant a project licence authorising the
use of cats, dogs, equidæ (horses, donkeys etc.) or non-human primates
unless he is satisfied that animals of no other species are suitable for the
purposes of the programme of work, or that it is not practicable to obtain
animals of any other species that are suitable for those purposes [Section
5(6)].
OTHER RESTRICTIONS
5.23 The Secretary of State has decided that licences will not be issued for
programmes of work involving:




the use of Great Apes (that is, chimpanzee, pygmy chimpanzee, gorilla
and orang-utan);
the use of protected animals for testing finished cosmetics products
and substances intended primarily for use as cosmetics ingredients;
the use of protected animals for the development or testing of alcohol
or tobacco products (the use of tobacco or alcohol as research tools
may, however, still be considered and licensed in the context of
investigating disease or novel treatments); or
the use of protected animals for the development or testing of offensive
weapons (licences may still be granted for the testing and development
of means for protecting or treating UK servicemen and women, or the
wider population).
PROJECT LICENCES FOR EDUCATION AND TRAINING
5.24 In considering project licence applications for education and training, the
Home Office makes the following practical distinction between education and
training:


education is the transfer of knowledge or the ability to formulate and
test hypotheses;
training is the development or maintenance of manual skills.
5.25 Project licences will not be issued for education and training in primary or
secondary schools.
5.26 Educational projects should be for the purpose of educating those who
will ultimately be responsible for the design, conduct, or analysis of scientific
work involving the use of living animals, and for whom an understanding of in
vivo biological phenomena in protected animals is essential. The teaching
objective must be specific, and not attainable by more refined methods, or
means not requiring the performance of regulated procedures on living
animals. It is expected that the teaching syllabus will also cover the ethics of
animal use for scientific purposes. The severity limit of protocols in such
projects should be either unclassified or mild (see paragraphs 5.40-5.42).
5.27 Teaching methods and materials are constantly being improved. Project
licences for educational purposes, and the specific teaching objectives being
pursued, should be reviewed at least annually to ensure that adequate
consideration is given to identify and implement relevant replacement,
reduction and refinement alternatives.
5.28 Project licences for training purposes are only issued for the training of
practising surgeons in micro-vascular techniques, when applicants can
demonstrate that no available alternative methods can achieve the specific
training objectives.
5.29 Applications for the purposes of education and training should not be
combined with applications for other permissible purposes.